State Key Laboratory of Molecular Oncology, Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, P. R. China.
Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, P. R. China.
Hepatology. 2021 Nov;74(5):2595-2604. doi: 10.1002/hep.31993. Epub 2021 Sep 16.
Surgical resection is the primary treatment for HCC; however, it is associated with a high rate of recurrence and death. We conducted this phase 2 study to investigate the efficacy and safety of postoperative intensity-modulated radiotherapy (IMRT) for HCC after narrow-margin hepatectomy.
We designed a single-arm, prospective phase 2 trial to evaluate overall survival (OS), disease-free survival (DFS), recurrence patterns, and toxicity in patients receiving adjuvant radiotherapy. The eligibility criteria included the following: pathological diagnosis of HCC after hepatectomy, with narrow pathological margins (< 1 cm); age > 18 years; and Eastern Cooperative Oncology Group performance status score of 0 or 1. Patients received IMRT within 4-6 weeks after surgical resection. This trial was registered at ClinicalTrials.gov (NCT01456156). Between 2008 and 2016, a total of 76 eligible patients who underwent narrow-margin resection were enrolled. The median follow-up duration was 70 months; the 3-year OS and DFS rates were 88.2% and 68.1%, respectively; and the 5-year OS and DFS rates were 72.2% and 51.6%, respectively. Intrahepatic recurrence was the primary recurrence pattern. No marginal recurrence was found. Intrahepatic, extrahepatic, and combined recurrences at the first relapse were found in 33, 5, and 1 patient, respectively. The most common radiation-related grade-3 toxicities were leukopenia (7.9%), elevated alanine aminotransferase (3.9%) and aspartate aminotransferase (2.6%) levels, and thrombocytopenia (1.3%). Classical or nonclassical radiation-induced liver disease was not noted.
Adjuvant radiotherapy is an effective, well-tolerated, and promising adjuvant regimen in patients with HCC who have undergone narrow-margin hepatectomy. Our trial provides evidence and a rationale for planning a future phase 3 trial.
手术切除是 HCC 的主要治疗方法，但它与高复发率和死亡率相关。我们进行这项 2 期研究，以调查窄切缘肝切除术后 HCC 术后调强放疗（IMRT）的疗效和安全性。
我们设计了一项单臂、前瞻性 2 期试验，以评估接受辅助放疗的患者的总生存率（OS）、无病生存率（DFS）、复发模式和毒性。纳入标准包括以下内容：肝切除术后病理诊断为 HCC，且病理切缘较窄（<1cm）；年龄>18 岁；东部肿瘤协作组体能状态评分为 0 或 1。患者在手术切除后 4-6 周内接受 IMRT。本试验在 ClinicalTrials.gov（NCT01456156）注册。2008 年至 2016 年间，共纳入 76 例符合条件的行窄切缘切除术的患者。中位随访时间为 70 个月；3 年 OS 和 DFS 率分别为 88.2%和 68.1%；5 年 OS 和 DFS 率分别为 72.2%和 51.6%。肝内复发是主要的复发模式。未发现切缘复发。首次复发时肝内、肝外和联合复发分别为 33、5 和 1 例。最常见的与放疗相关的 3 级毒性为白细胞减少（7.9%）、丙氨酸转氨酶（3.9%）和天冬氨酸转氨酶（2.6%）升高以及血小板减少（1.3%）。未发现经典或非经典放射性肝损伤。
辅助放疗是一种有效、耐受良好且有前途的 HCC 患者窄切缘肝切除术后的辅助治疗方案。我们的试验为计划未来的 3 期试验提供了证据和理由。
